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Tell Me Fast COVID-19 Neutralizing Antibody Test
CE APPROVED
Covid-19 Neutralizing Antibody Test
Now Available!
Biocan is an ISO 13485:2016 MDSAP certified manufacturer of various rapid in-vitro diagnostics tests made under stringent quality control in our facility near Vancouver, Canada.
As part of our corporate mission, we have launched the COVID-19 Antigen Test at a very reasonable cost to make it affordable to where it is needed most. We believe accessible testing is key to stop the spread of Novel Coronavirus, which has now affected many people worldwide and is spreading rapidly.
Our COVID19 Antigen Test is currently not approved for sale in Canada.
Intended Use:
Biocan Tell Me Fast SARS-CoV-2 (COVID-19) Neutralizing Antibody Rapid Test is a rapid in vitro semi-quantitative, membrane-based immunochromatographic assay intended for detection neutralizing antibodies to SARS-CoV-2 in human serum, plasma (EDTA, citrate, Heparin) or venipuncture whole blood specimens (including finger prick) by a healthcare provider, laboratories, point of care and self-testing. The novel coronavirus neutralizing antibodies are protective antibody produced by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. This test is used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection and to monitor the presence of neutralizing antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus. It can be used to evaluate the immune effect after vaccination or whether neutralizing antibodies are produced in human body after infection with novel coronavirus. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time neutralizing antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute SARS-CoV-2 infection.
Principle of the Test:
Biocan Tell Me Fast SARS-CoV-2 (COVID-19) Neutralizing Antibody Rapid Test is a lateral flow chromatographic immunoassay for the semi-quantitative detection of SARS-CoV-2 neutralizing Antibody after vaccination or after infection with SARS-CoV-2 virus in human serum, plasma and whole blood. The test strip consists of a strip which consists of a burgundy-colored conjugate pad containing SARS-COV-2 S-RBD antigen conjugated with colloidal gold (SARS CoV-2 conjugates) and mouse IgG-gold conjugates and a nitrocellulose membrane strip containing one test band (T) and a control band (C band). The test band is pre-coated with SARS-COV-2 ACE2 antigen for competitively binding to RBD with neutralizing antibody, to detect the neutralizing antibody in serum, plasma and whole blood. The C band is pre-coated with goat anti mouse IgG. When an adequate volume of test specimen is dispensed into the sample pad of the test strip, the specimen migrates by capillary action across the strip. If there is antibody produced after vaccine, the RBD antibody will be conjugated with RBD antigen, thus the ACE2 antigen can not bind to RBD antigen, so the test line will not be colored, and its intensity will be lower than that of the C band indicating a positive result. If no antibodies are produced, the ACE2 antigen will bind to RBD antigen, the test line will be colored with same or higher intensity than the C band indicating a negative result.